Anurag Sharma, PhD U.S. FDA

Anurag Sharma joined Food and Drug Administration (FDA)/CBER/OTP as a gene therapy product reviewer in October 2018 and conducts scientific review of CMC data to assess safety and quality of diverse investigational gene therapy products. He has been Acting Team Lead since August 2022 and has been helping and training new reviewers to perform regulatory review of gene therapy products. Anurag earned his bachelor’s degree in veterinary sciences and master’s in animal biotechnology from India before moving to the United States to pursue PhD in Molecular Virology from Purdue University at West Lafayette, IN. His doctoral research primarily focused on the development and characterization of novel adenoviral vectors for gene delivery applications. After his PhD, Anurag worked at Weill Cornell Medicine (WCM) at New York City as a postdoctoral associate and subsequently as an Assistant Professor of Research. At WCM, he continued his research to design innovative strategies to further improve adenoviral vectors and to develop vaccines against some of the pediatric respiratory infections with no approved vaccines. He also holds Regulatory Affairs Certification (RAC) offered by Regulatory Affairs Professionals Society (RAPS).